PMDA drug package insert

エスシタロプラムOD錠10mg「トーワ」

PMDA Prescription drug · 東和薬品株式会社 · package insert Mar 5, 2024

Key facts

Brand names エスシタロプラムOD錠10mg「トーワ」, エスシタロプラムOD錠20mg「トーワ」
Nonproprietary names エスシタロプラムシュウ酸塩
Companies 製造販売元/東和薬品株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category 選択的セロトニン再取り込み阻害剤(SSRI)
Therapeutic category codes 871179
YJ codes 1179054F3041, 1179054F4048
Approval numbers 30400AMX00343, 30400AMX00344
Package insert edition 第3版
Package insert date Mar 5, 2024
PMDA document key 480235_1179054F3041_2
PMDA company code 480235

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

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